Consistent Dosing Over Time And Within Treatment Interval Groups With Onabotulinumtoxina: Analysis from the Adult Spasticity International Registry (ASPIRE)

Abstract

<h3>Research Objectives</h3> To examine the relationship between real-world dosing and treatment intervals of onabotulinumtoxinA for adult spasticity <h3>Design</h3> Post hoc analysis of data collected from the prospective, observational, international Adult Spasticity International Registry (ASPIRE; NCT01930786) for multiple etiologies over 2 years. Patients were split into treatment interval groups (N=2373): < 12, 12-14, 15-17, 18-20, and ≥ 21 weeks. Treatment adherence defined as ≥ 3 treatment sessions with onabotulinumtoxinA over 2-year period. <h3>Setting</h3> International clinical sites. <h3>Participants</h3> Adults (N=730) with focal spasticity. <h3>Interventions</h3> OnabotulinumtoxinA dosing and treatment intervals at physician's discretion. <h3>Main Outcome Measures</h3> Patient satisfaction items and adverse events (AEs) were assessed. <h3>Results</h3> OnabotulinumtoxinA doses were generally constant over the treatment interval groups, with the lowest mean dose 335U (≥ 21 weeks) and highest dose 387U (12-14 weeks). Patients naïve to toxin at baseline received slightly lower doses in each treatment interval group than non-naïve, with respective doses ranging from 305-372U and 346-396U. Most patients (63-76%) received ≤400U across all treatment intervals. Mean doses slightly increased over treatment sessions, from 355U at session 2 to 394U at session 7. Treatment-adherent patients reported high rates of satisfaction over treatment sessions: 81-92% stated their most recent onabotulinumtoxinA treatment helped their spasticity, 73-82% were satisfied/extremely satisfied with how long they felt onabotulinumtoxinA working, and 91-96% planned to continue using onabotulinumtoxinA to treat their spasticity. The most commonly reported AEs were fall (5.5%), urinary tract infection (2.6%), and muscular weakness (2.6%). <h3>Conclusions</h3> Dosing of onabotulinumtoxinA to treat adult spasticity remained consistent over treatment sessions and regardless of the length of the treatment interval, with most patients receiving onabotulinumtoxinA within approved dosing ranges. High patient satisfaction was observed, with no new safety signals. <h3>Author(s) Disclosures</h3> AE: Consulted for Allergan(AbbVie). Research grants from Allergan(AbbVie); WF: Research grant from Ipsen; GFW: None reported; PG: Research grants from Allergan(AbbVie); AB: Consulted for, and received research grants from Allergan(AbbVie); KF: Employee of Vedanta Research, which received support funded by Allergan(AbbVie); AZ: Employee of Allergan(AbbVie); GEF: Consulted for, and received research grants from, Allergan(AbbVie); DSB: Research support from Allergan(AbbVie).